Adverse event reports
Executive Summary
Pfizer "has been implementing remedial actions designed to remedy" issues raised in an April 1996 FDA warning letter, the company's annual report discloses. The letter concerned "timeliness and completeness of required post-marketing reports" and corrective action was discussed with the agency in 1997. "A full examination of the progress made by the company in this area will occur in 1999," the annual report states. Pfizer received an FDA warning letter in December regarding incomplete formulation warnings from Trovan clinical trials (1"The Pink Sheet" Jan. 11, p. 13)
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